Glimepiride

Product NDC
60760-800
11-digit product format
607600800
Labeler code
60760
Product ID
60760-800_fc9df15f-22a5-f7a1-e053-6294a90a5b6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA202759
Marketing category
ANDA
Marketing start
2023-05-19
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6KY687524KGLIMEPIRIDE93479-97-1GLIMEPIRIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-800-906076008009090 TABLET in 1 BOTTLE, PLASTIC (60760-800-90) 90 tablet2023-05-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GlimepirideST. MARY'S MEDICAL PARK PHARMACY2023-05-26HUMAN PRESCRIPTION DRUG LABEL1